ISO 13485 LI Practice Questions - PECB Certified ISO 13485 Lead Implementer Exam

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ISO 13485:2016 deliberately did NOT adopt the Annex SL High Level Structure used by ISO 9001:2015. What was the primary reason?

PECB required a unique structure The medical device community chose to preserve regulatory stability and avoid disrupting FDA, EU MDR, and other regulatory dependencies ISO 13485 is only applicable in Europe Annex SL was not published until after ISO 13485:2016

Correct Answer:

The medical device community chose to preserve regulatory stability and avoid disrupting FDA, EU MDR, and other regulatory dependencies

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